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Rotavirus Vaccine Gets FDA Warning

Rotavirus is the leading cause of early childhood diarrhea. A new vaccine to protect against rotavirus has recently received a government warning. The FDA says that the vaccine, called RotaTeq, may be linked to a condition called intussusception, which is twisting of the intestines. The condition also occurs spontaneously. However, an increased risk of intussusception caused the market withdrawal of an earlier rotavirus vaccine in 1999. The recent FDA warning about RotaTeq was caused by 28 reported cases of intestinal twisting in infants, including 16 who required surgery. The FDA’s recent warning sought to encourage reporting of intestinal twisting cases and also indicated that RotaTeq’s label would mention intussusception. RotaTeq is manufactured by Merck, which insists that the reported cases are well below the number of cases expected to occur naturally.

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